Quality of Life Evaluation With the SRI Questionnaire of ALS Patient With Non-invasive Ventilation

Not Applicable

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: Score completion

• Registration Number: NCT05498883
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

This study aims to measure the quality of life of ALS patients by the SRI questionnaire, in two distinct patient groups : Patient requiring initiation of NIV, and patients 24 hours dependent on NIV

This study also seeks to assess the quality of life of the caregivers with the Zarit Burden interview in those two populations

Detailed Description

The course of the study is as follows:

Patient newly ventilated with NIV :

inclusion is done on the day of starting NIV. On the day of inclusion: Clinical examination, completion of the ALS-FRS score, completion of the SRI score.

For the caregiver: Completion of the Zarit Burden Inerview Reassessment of scores (SRI, Zarit-burden, ALS-FRS), at three-month and six-month follow-up

Patient dependent of NIV :

On the day of inclusion: Clinical examination, completion of the ALS-FRS score, completion of the SRI score.

For the caregiver: Completion of the Zarit Burden Inerview Reassessment of scores (SRI, Zarit-burden, ALS-FRS), at three-month follow-up

Study Timeline

• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-12
• Study Start: 2022-09-13
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25
• Primary Completion: 2024-09-13
• Study Completion: 2024-09-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Patients :

• 18 years or more
• Patient followed for ALS probable or certain with Awaji criteria
• group 1 : severe chronic respiratory failure, with a decision by the attending physician to start NIV
• group 2 : complete dependence on NIV

Caregivers :

• 18 years or more
• Informed and does not object to the study
• Primary caregiver for more than 3 months of an ALS patient on NIV (either at initiation or with 24 hours NIV dependence)
• More than 30 hours spent at home per week
• Met the inclusion criteria for group 1 (NIV initiation) or group 2 (24 hours NIV dependence)

Exclusion Criteria

Patients :

• Patient under legal protection/ guardianship
• insufficient command of French
• Severe cognitive impairment, particularly in relation to frontotemporal degeneration
• No indication criteria for NIV.

Caregivers :

• insufficient command of French
• Caregiver of a patient with another chronic pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient requiring NIV	Score completion	Clinical examination, completion of the ALS-FRS score, completion of the SRI score.

Primary Outcome Measures

Name	Time	Method
SRI questionnaire in patients who have indication for starting NIV	six months	SRI questionnaire assessment at initiation of NIV, at 3-month follow-up and at 6-month follow-up

Secondary Outcome Measures

Name	Time	Method
SRI of patients with total ventilatory dependence in ALS	three months	SRI questionnaire assessment at inclusion and at 3-month follow-up
Zarit burden interview in both groups	Six months	Zarit Burden interview questionnaire in ALS patient caregiver, in both groups (initiation of NIV and NIV-dependent patients) at inclusion, 3-month follow-up (both groups) and at 6-month follow-up (in group 1)

Trial Locations

Locations (1)

Pneumology departement, Pitié-Salpêtrière hospital, GHU APHP-Sorbonne Université; 🇫🇷 Paris, France